Delayed-release formulation for reducing the frequency of urination and method of use thereof

Abstract

Methods and compositions for reducing the frequency of urination are disclosed. One method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising an analgesic agent formulated in a delayed-release formulation. Another method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising multiple active ingredients. Yet another method comprises administering to a subject in need thereof an effective amount of a diuretic followed with another administration of a pharmaceutical composition comprising an analgesic agent.

1 - 30 . (canceled) 
     
     
         31 . A method for reducing the frequency of urination, comprising:
 administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated in delayed-release formulation,   wherein said acetaminophen is administered at a daily dose of 5 mg to 2000 mg.   
     
     
         32 . The method of  claim 31 , wherein said acetaminophen is administered at a daily dose of 100 mg to 500 mg. 
     
     
         33 . The method of  claim 31 , wherein said acetaminophen is administered at a daily dose of 500 mg to 2000 mg. 
     
     
         34 . The method of  claim 31 , wherein said acetaminophen is administered at a daily dose of 50 mg to 1600 mg. 
     
     
         35 . The method of  claim 31 , wherein said pharmaceutical composition further comprises one or more antimuscarinic agents. 
     
     
         36 . The method of  claim 31 , wherein said pharmaceutical composition further comprises one or more antidiuretics. 
     
     
         37 . The method of  claim 31 , wherein said pharmaceutical composition further comprises one or more spasmolytics. 
     
     
         38 . The method of  claim 31 , wherein said delayed-release formulation comprises a material selected from the group consisting of hydroxypropyl methylcellulose, methylcellulose, methyl hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, acrylate copolymers, polyethylene glycols, polyvinylpyrrolidone, methacrylic acid copolymer, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, hydroxypropyl methylcellulose acetate succinate, polyvinyl acetate phthalate, shellac, and ethylcellulose. 
     
     
         39 . The method of  claim 31 , wherein said delayed-release formulation comprises glyceryl monostearate or glyceryl distearate. 
     
     
         40 . The method of  claim 31 , wherein said delayed-release formulation comprises a water insoluble capsule body closed at one end with an insoluble, but permeable and swellable hydrogel plug, wherein said plug comprises a material selected from the group consisting of polymethacrylates, erodible compressed polymers, congealed melted polymer and enzymatically controlled erodible polymers. 
     
     
         41 . The method of  claim 31 , wherein said delayed-release formulation comprises an enteric coating. 
     
     
         42 . The method of  claim 31 , wherein said pharmaceutical composition further comprises one or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone. 
     
     
         43 . The method of  claim 31 , wherein said pharmaceutical composition is administered orally. 
     
     
         44 . The method of  claim 31 , wherein said pharmaceutical composition is formulated for the oral administration. 
     
     
         45 . A method for reducing the frequency of urination, comprising:
 administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated for immediate release,   wherein said acetaminophen is administered at a daily dose of 10 mg to 2000 mg.   
     
     
         46 . The method of  claim 45 , wherein said acetaminophen is administered at a daily dose of 100 mg to 500 mg. 
     
     
         47 . The method of  claim 45 , wherein said acetaminophen is administered at a daily dose of 250 mg to 500 mg. 
     
     
         48 . The method of  claim 45 , wherein said acetaminophen is administered at a daily dose of 250 mg to 1000 mg. 
     
     
         49 . The method of  claim 45 , wherein said pharmaceutical composition further comprises one or more antimuscarinic agents selected from the group consisting of oxybutynin, solifenacin, darifenacin and atropine. 
     
     
         50 . The method of  claim 45 , wherein said pharmaceutical composition further comprises one or more antidiuretics. 
     
     
         51 . The method of  claim 45 , wherein said pharmaceutical composition further comprises one or more spasmolytics. 
     
     
         52 . The method of  claim 45 , wherein said pharmaceutical composition further comprises one or more analgesic agent selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone. 
     
     
         53 . A method for reducing the frequency of urination, comprising:
 administering to a subject who desires to reduce the frequency of urination an effective amount of a pharmaceutical composition comprising acetaminophen formulated in delayed-release formulation having an immediate-release component and a delayed-release component,   wherein said acetaminophen is administered at a daily dose of 5 mg to 2000 mg.   
     
     
         54 . The method of  claim 53 , wherein said s delayed-release component may also be an extended release component that is delayed. 
     
     
         55 . The method of  claim 53 , wherein said pharmaceutical composition further comprises one or more antimuscarinic agents in said immediate-release component, or said delayed-release component, or both components. 
     
     
         56 . The method of  claim 53 , wherein said pharmaceutical composition further comprises one or more antidiuretics in said immediate-release component, or said delayed-release component, or both components. 
     
     
         57 . The method of  claim 53 , wherein said pharmaceutical composition further comprises one or more spasmolytics in said immediate-release component, or said delayed-release component, or both components. 
     
     
         58 . The method of  claim 53 , wherein said pharmaceutical composition further comprises one or more analgesic agents in said immediate-release component, or said delayed-release component, or both components,
 wherein said one or more analgesic agents are selected from the group consisting of aspirin, ibuprofen, naproxen, naproxen sodium, indomethacin and nabumetone.   
     
     
         59 . The method of  claim 53 , wherein said pharmaceutical composition is administered orally. 
     
     
         60 . The method of  claim 53 , wherein said pharmaceutical composition is formulated for the oral administration. 
     
     
         61 . The method of  claim 53 , wherein said pharmaceutical composition further comprises one or more analgesic agents in said immediate-release component, extended, or said delayed-release component, or any combination of components.